HealthyPhase 1NCT06843460
A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)
A Phase 1 study testing Sotatercept in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial summary
The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 21 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a BMI≥18.0 kg/m^2 and ≤28.0 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has been treated with a sotatercept or luspatercept
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants
The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).
- Conditions
- Healthy
- Being tested
- Sotatercept, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called MK-7962, ActRIIA-IgG1Fc, ACE-011
Single subcutaneous injection
PlaceboOther
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sotatercept Dose Level 1 | Experimental | Participants received a single dose of sotatercept at dose level 1. Receives: Biological: Sotatercept |
| Sotatercept Dose Level 2 | Experimental | Participants received a single dose of sotatercept at dose level 2. Receives: Biological: Sotatercept |
| Placebo | Placebo comparator | Participants received a single dose of placebo to sotatercept. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 120 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to approximately 120 days
Maximum Serum Concentration (Cmax) of Sotatercept
Blood samples will be collected to determine the Cmax of sotatercept.
Measured: At designated timepoints (up to 120 days)
Time to Maximum Serum Concentration (Tmax) of Sotatercept
Blood samples will be collected to determine the Tmax of sotatercept.
Measured: Predose and at designated timepoints up to 120 days postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962
Blood samples will be collected to determine the AUC0-last of MK-7962.
Measured: At designated timepoints (up to 120 days)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962
Blood samples will be collected to determine the AUC0-inf of MK-7962.
Measured: At designated timepoints (up to 120 days)
Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962
Blood samples will be collected to determine the AUC0-28 days of MK-7962.
Measured: At designated timepoints (up to 28 days postdose)
Apparent Terminal Half-life (t1/2) of MK-7962
Blood samples will be collected to determine the t1/2 of MK-7962.
Measured: At designated timepoints (up to 120 days)
Apparent Clearance (CL/F) of MK-7962
Blood samples will be collected to determine the CL/F of MK-7962.
Measured: At designated timepoints (up to 120 days)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962
Blood samples will be collected to determine the Vz/F of MK-7962.
Measured: At designated timepoints (up to 120 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start22 Nov 2023
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The first 12 participants were randomized 1:3 between placebo or 0.3 mg/kg of sotatercept. After those 12 participants were complete, the next 12 were randomized 1:3 between placebo or 0.7 mg/kg of sotatercept.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843460
- Sponsor's protocol ID
- 7962-021
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06843460
- Acronym / sponsor ID
- 7962-021
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them. The study will also measure what happens to sotatercept in a person's body over time (pharmacokinetic or PK study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The first 12 participants were randomized 1:3 between placebo or 0.3 mg/kg of sotatercept. After those 12 participants were complete, the next 12 were randomized 1:3 between placebo or 0.7 mg/kg of sotatercept.
| Arm | Type | Receives |
|---|---|---|
| Sotatercept Dose Level 1 | Experimental | Biological: SotaterceptParticipants received a single dose of sotatercept at dose level 1. |
| Sotatercept Dose Level 2 | Experimental | Biological: SotaterceptParticipants received a single dose of sotatercept at dose level 2. |
| Placebo | Placebo comparator | Other: PlaceboParticipants received a single dose of placebo to sotatercept. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has a BMI≥18.0 kg/m^2 and ≤28.0 kg/m^2
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has been treated with a sotatercept or luspatercept
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotaterceptAlso: MK-7962, ActRIIA-IgG1Fc, ACE-011Single subcutaneous injection | Biological | Sotatercept Dose Level 1, Sotatercept Dose Level 2 |
| PlaceboSingle subcutaneous injection | Other | Placebo |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 120 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 120 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Maximum Serum Concentration (Cmax) of Sotatercept
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the Cmax of sotatercept.
Time to Maximum Serum Concentration (Tmax) of Sotatercept
Time frame: Predose and at designated timepoints up to 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-7962
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the AUC0-last of MK-7962.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7962
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the AUC0-inf of MK-7962.
Area Under the Concentration-Time Curve from Time 0 to 28 days (AUC0-28 days) of MK-7962
Time frame: At designated timepoints (up to 28 days postdose)
Blood samples will be collected to determine the AUC0-28 days of MK-7962.
Apparent Terminal Half-life (t1/2) of MK-7962
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the t1/2 of MK-7962.
Apparent Clearance (CL/F) of MK-7962
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the CL/F of MK-7962.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-7962
Time frame: At designated timepoints (up to 120 days)
Blood samples will be collected to determine the Vz/F of MK-7962.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sotatercept in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 120 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.